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Burdle, The FDA will approve of something like Infuse kits (BMP), but only if trained in its usage, and particular procedure. If used in any other procedure that's not recommended or approved, its considered "off label". Surgeons are allowed to do "off label" procedures before the FDA gives a green light. (Tethering is a good example)(Magec is a good example) Surgeons need to be trusted that they are doing what they feel will benefit a patient, should something go wrong and end up in a courtroom, its mainly about intent. I signed a few waivers stating that I was informed of discussed complications of my procedure.

So, a product approved with stipulations, but no control over its usage. BMP is approved for ALIF surgery only in scoliosis surgery. Not for posterior procedures.

In UK we have NATIONAL INSTITUTE OF CLINICAL EXCELLENCE. But this body 'regulates' procedures. The remit is are they 'cost effective'- it is a different perspective

I guess from an FDA point of view you cant do a procedure if there are no devices that have been approved for it ( notwithstanding 'off-label). In UK Tethering is not on the table because of NICE but it is the procedure itself. However if/when it is approved it will have to be with the use of certain devices. I need to find out how devices get approved in UK

Burdle, The FDA will approve of something like Infuse kits (BMP), but only if trained in its usage, and particular procedure. If used in any other procedure that's not recommended or approved, its considered "off label". Surgeons are allowed to do "off label" procedures before the FDA gives a green light. (Tethering is a good example)(Magec is a good example) Surgeons need to be trusted that they are doing what they feel will benefit a patient, should something go wrong and end up in a courtroom, its mainly about intent. I signed a few waivers stating that I was informed of discussed complications of my procedure.

So, a product approved with stipulations, but no control over its usage. BMP is approved for ALIF surgery only in scoliosis surgery. Not for posterior procedures.

I have resurrected this because I am unclear still - does a procedure have to be approved by the FDA as well? Can you have a procedure approved like VBT with the actual device being off-label? If so what difference would it make for the device to become approved?

Any use of tethers in the US is considered experimental. There is no data confirming safety in adults.

They mention a paucity or scarcity of information.

I have 2 long posts written for you on the other webinar thread since you present a good argument about gold standard. But I am still sick with the flu, and I keep thinking about a pin head of virus being able to make 20,000 people sick.